Spinous process fusion devices

ABSTRACT

The present disclosure generally relates to a device for positioning and immobilizing at least two adjacent vertebrae. In particular, in one or more embodiments, the present disclosure relates to spinous process fusion devices that distract and immobilize the spinous processes of adjacent vertebrae.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation application claiming priorityto U.S. patent application Ser. No. 12/557,819, filed on Sep. 11, 2009,the entire content of which is incorporated by reference.

FIELD OF THE INVENTION

The present disclosure generally relates to a device for positioning andimmobilizing at least two adjacent vertebrae. In particular, in one ormore embodiments, the present disclosure relates to spinous processfusion devices that distract and/or immobilize the spinous processes ofadjacent vertebrae.

BACKGROUND

Bones and bony structures are susceptible to a variety of weaknessesthat can affect their ability to provide support and structure.Weaknesses in bony structures may have many causes, includingdegenerative diseases, tumors, fractures, and dislocations. Advances inmedicine and engineering have provided doctors with a plurality ofdevices and techniques for alleviating or curing these weaknesses.

Typically, weaknesses in the spine are corrected by using devices thatfuse one or more vertebrae together. Common devices involve platesystems that align and maintain adjacent vertebrae in a desiredposition, with desired spacing. These devices, commonly referred to asbone fixation plating systems, typically include one or more plates andscrews for aligning and holding vertebrae in a fixed position withrespect to one another. When implanting these devices in a patient, itmay be desirable for interspinous distraction, for example, to obtain adesired spacing between the fused spinous processes.

Thus, there is a need for a device that provides structural stability toadjacent vertebrae, for example, a plate system that can distract and/orimmobilize the spinous processes of adjacent vertebrae.

SUMMARY OF THE INVENTION

An embodiment of the present invention provides an implantable device.The implantable device may comprise a body, a first wing coupled to thebody, and a second wing, wherein a ratcheting lock secures the secondwing on the body.

The features and advantages of the present invention will be readilyapparent to those skilled in the art. While numerous changes may be madeby those skilled in the art, such changes are within the spirit of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a lateral view of one embodiment of a spinous process fusiondevice of the present invention having a ratcheting lock.

FIG. 2 is a top view of an embodiment of the spinous process fusiondevice of FIG. 1.

FIG. 3 is a lateral view of one embodiment of the spinous process fusiondevice of the present invention with one of the wings removed.

FIG. 4 is a view of one embodiment of a wing for use with an embodimentof a spinous process fusion device of the present invention.

FIG. 5 is a view of another embodiment of a wing for use with anembodiment of a spinous process fusion device of the present invention.

FIG. 6 is a view of one embodiment of a ratcheting lock for use with anembodiment of a spinous process fusion device of the present invention.

FIG. 7 is a cross-sectional view of the ratcheting lock of FIG. 6.

FIG. 8 is a lateral view of another embodiment of a spinous processfusion device of the present invention having a ratcheting lock and acentral barrel.

FIG. 9 is a top view of an embodiment of the spinous process fusiondevice of FIG. 8.

FIG. 10 is a lateral view of another embodiment of a spinous processfusion device of the present invention having a ratcheting lock and apivoting wing.

FIG. 11 is a lateral view of one embodiment of the spinous processfusion device of FIG. 10 with one of the wings removed.

FIG. 12 is a perspective view of another embodiment of a spinous processfusion device of the present invention having a ratcheting lock and anexpandable wing.

FIG. 13 is a lateral view of an embodiment of the spinous process fusiondevice of FIG. 12 with the expandable wing in a folded position.

FIG. 14 is a lateral view of an embodiment of the spinous process fusiondevice of FIG. 12 with the expandable wing in an upright position.

FIG. 15 is a perspective view of another embodiment of a spinous processfusion device of the present invention having an expandable wing with aflange.

FIG. 16 is a lateral view of an embodiment of the spinous process fusiondevice of FIG. 15 with the expandable wing in a folded position.

FIG. 17 is a lateral view of an embodiment of the spinous process fusiondevice of FIG. 15 with the expandable wing in an upright position andthe flange extended.

FIG. 18 is a perspective view of another embodiment of a spinous processfusion device of the present invention having an expandable wing.

FIG. 19 is a lateral view of an embodiment of the spinous process fusiondevice of FIG. 18 with the expandable wing in a folded position.

FIG. 20 is a lateral view of an embodiment of the spinous process fusiondevice of FIG. 19 with the expandable wing in an upright position.

FIG. 21 is a perspective view of another embodiment of a spinous processfusion device of the present invention.

FIG. 22 is a lateral view of an embodiment of the spinous process fusiondevice of FIG. 21.

FIG. 23 is a view of a wing for use with an embodiment of a spinousprocess fusion device of the present invention.

FIG. 24 is a perspective view of an embodiment of a spinous processfusion device of the present invention having a slot for insertion ofthe second wing.

FIG. 25 is a lateral view of an embodiment of the spinous process fusiondevice of FIG. 24 with the second wing removed.

FIG. 26 is a lateral view of an embodiment of the spinous process fusiondevice of FIG. 24 with the second wing ratcheted in place.

FIG. 27 is a top view of an embodiment of the spinous process fusiondevice of FIG. 24.

FIG. 28 is a top view of an embodiment of the spinous process fusiondevice of FIG. 24 with angulation of the wings.

FIG. 29 is a perspective view of another embodiment of a spinous processfusion device of the present invention having clampable wings.

FIG. 30 is a lateral view of an embodiment of the spinous process fusiondevice of FIG. 29 with the clampable wings in an open position.

FIG. 31 is a lateral view of an embodiment of the spinous process fusiondevice of FIG. 29 with the clampable wings in a closed position.

FIG. 32 is a perspective view of an embodiment of a spinous processfusion device of the present invention having a plate in the generalshape of an arrowhead.

FIGS. 33-34 are lateral views of an embodiment of a spinous processfusion device of the present invention having a pivoting scissor-typeclamp.

FIGS. 35-36 are lateral view of an embodiment of a spinous processfusion device of the present invention having expandable wings.

FIGS. 37-38 are lateral views of an embodiment of a spinous processfusion device of the present invention having distraction elements.

FIG. 39 is an end view of an embodiment of the spinous process fusiondevice of FIG. 38.

FIG. 40 is a perspective view of another embodiment of the spinousprocess fusion device of the present invention.

FIGS. 41-42 are lateral view of another embodiment of the spinousprocess fusion device of the present invention having a plate in thegeneral shape of an arrowhead.

FIG. 43 is a perspective view of an embodiment of a spinous processfusion device of the present invention having a central bolt for drawingthe first and second wings together.

FIG. 44 is a top view of an embodiment of the spinous process fusiondevice of FIG. 43.

FIGS. 45-47 illustrate an embodiment of a spinous process fusion deviceof the present invention that includes a camlock.

FIGS. 48-51 illustrate an embodiment of a spinous process fusion deviceof the present invention that includes a spreader-type lock.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

The present disclosure generally relates to a device for positioning andimmobilizing at least two adjacent vertebrae. In particular, in one ormore embodiments, the present disclosure relates to spinous processfusion devices that distract and/or immobilize the spinous processes ofadjacent vertebrae. The fusion devices may be implanted in a patient,for example, without the need for removal of the supraspinous ligament.In certain embodiments, the fusion devices provide for distraction ofthe interspinous space, for example, allowing use of the device as aspacer and a clamp.

FIGS. 1-2 illustrate a spinous process fusion device 10 in accordancewith embodiments of the present invention. As illustrated, the spinousprocess fusion device 10 may comprise a body 15, a first wing 20 coupledto the body, and a second wing 25. In accordance with embodiments of thepresent invention, the second wing 25 may be secured to the body 15 by aratcheting lock. When installed in a patient, the first wing 20 and thesecond wing 25 may engage spinous processes of adjacent vertebra aboveand below the interspinous space. The device 10 should thus, forexample, immobilize the lumbar motion segment associated with thevertebrae of the engaged spinous processes. In certain embodiments, thedevice 10 should immobilize the lumbar motion segment without the needfor additional devices.

An embodiment of the body 15 will be described with reference to FIGS.1-3. It should be understood that the first wing 20 is not illustratedon FIG. 3 to more particularly illustrate certain details of the body15. The body 15 may have a length, for example, of about 20 millimetersto about 50 millimeters. As illustrated, the body 15 may comprise a rod30, a connector portion 35, and head 40. The connector portion 35connects the rod 30 and the head 40. The rod 30 generally may beconfigured so that it can spread to increase the diameter of the rod 30.In the illustrated embodiment, the rod 30 has an opening 45 extendingthere through in the direction of the longitudinal axis. In certainembodiments, the rod 30 may be configured so that insertion of a pin 50or screw into the opening 45 spreads the rod 30. As such, the diameterof the rod 30 may be increased. The rod 30 further includes a taperedend 55 opposite the head 40.

The rod 30 further may include a series of ratchet receivers thatcomprise protuberances 60. The protuberances 60 may be, for example, inthe shape of an inclined wedge with the inclined portion of theprotuberance extending in the direction of the tapered end 55 of the rod30. As illustrated, the protuberances 60 may be arranged along thelongitudinal axis of the rod 30. The protuberances 60 further may bearranged on a first and a second side of the rod 30. In the illustratedembodiment, the protuberances 60 are integrally formed with the rod 30.

An embodiment of the first wing 20 will be described in more detail withrespect to FIGS. 1-2 and 4. The first wing 20 may extend transverselyfrom the body 15 and be disposed over the connecting portion 35 of thebody 15 between the rod 30 and the head 40. The first wing 20 may have alength sufficient to span, for example between adjacent spinousprocesses, such as about 20 millimeters to about 60 millimeters. Thefirst wing 20 may comprise an upper portion 65, a central portion 70, alower portion 75, and teeth 80. The upper portion 65 and the lowerportion 75 may have widths respectively of about 10 millimeters to about80 millimeters, while the central portion 70 may have a width of about 5millimeters to about 10 millimeters. In the illustrated embodiment, theupper portion 65 and the lower portion 75 are each generally rectangularin shape. It should be understood that other shapes for these portionsof the first wing 20 may also be suitable. By way of example, the wingmay be rectangular with rounded corners, oval, circular, footballshaped, wedge-shaped, and a variety of other shapes suitable for aparticular application.

An alternative embodiment of the first wing 20 is illustrated in FIG. 5.As illustrated in FIG. 5, each of the upper portion 65 and the lowerportion 75 may have a cutout, for example, to facilitate stacking ofmore than one spinous process fusion device 10. The cutout may beconfigured so that the upper portion 65 and the lower portion 75 of thefirst wing 20 mate. In this manner, an upper portion 65 of one spinousprocess fusion device 10 may engage the same spinous process as thelower portion 75 of another fusion device 10. While not illustrated, thefirst wing 20 may be configured to angulate on the connector portion 35,for example, to conform to the patient's anatomy. By way of example, thefirst wing 20 may be configured to rotate about its longitudinal axis.

Referring again to FIGS. 1-2 and 4, the central portion 70 of the firstwing may have an opening 85 that should allow the first wing 20 to beplaced onto the connecting portion 35. The opening 85 should beconfigured so that the first wing 20 cannot be removed from theconnecting portion 35 over the rod 30. The first wing 20 may include theteeth 80 (e.g., spikes) for engaging the spinous processes. By way ofexample, the teeth 80 may bite into the spinous processes clamping thespinous processes in position. As illustrated, the teeth 80 extend fromthe side of the first wing 20 that is facing the second wing 25.

Second wing 25 may be placed onto the rod 30 over the protuberances 60,in accordance with embodiments of the present invention. Second wing mayextend transversely from the body 15. The second wing 25 may have alength sufficient to span, for example between adjacent spinousprocesses, such as about 20 millimeters to about 60 millimeters. Asillustrated, the second wing 25 may comprise upper portion 90, centralportion 95 and lower portion 100. The upper portion 90 and lower portion100 may have widths respectively of about 10 millimeters to about 20millimeters, while the central portion 95 may have a width of about 5millimeters to about 10 millimeters. As described above with respect tothe first wing 20, the upper portion 90 and the lower portion 100 of thesecond wing 25 may also be rectangular shaped or any other shapesuitable for a particular application. In addition, to facilitatestacking, the upper portion 90 and the lower portion 100 may also havecutouts, in certain embodiments. The second wing 25 further may includeteeth 105 (e.g., spikes) for engaging the spinous processes. The teeth105 may, for example, bite into the spinous process clamping them inposition. In the illustrated embodiment, the teeth 105 may extend fromthe side of the second wing 25 that is facing the first wing 20.

Referring now to FIGS. 6-7, the second wing 25 further may include anopening 110 that should allow the second wing 25 to be placed onto therod 30. The interior wall 115 of the second wing 25 surrounding theopening 100 may include ratcheting members 120, 125, 130 that extendoutwardly from the interior wall 115. A first ratcheting member 120 mayextend from the interior wall 115 at one edge of the opening 110. Thefirst ratcheting member 120 may be grooved so that it fits over acorresponding one of the protuberances 60. A second ratcheting member125 may extend from the interior wall 115 in the central area of theinterior wall 115. The second ratcheting member 125 may be in the shapeof an inclined wedge with the inclined portion in the opposite directionof the inclined portion of the protuberances 60 so that the secondratcheting member 125 fits into a space between adjacent protuberances60. The third ratcheting member 130 may extend from the interior wall115 at the opposite edge of the opening 110 from the first ratchetingmember 120. The third ratcheting member 130 may also be grooved so thatit fits over a corresponding one of the protuberances 60.

When the second wing 25 is placed over the rod 30, the ratchetingmembers 120, 125, 130 should interact with the protuberances 60 tocreate a one-way ratcheting lock, in accordance with embodiments of thepresent invention. By way of example, the ratcheting members 120, 125,130 and the protuberances 60 should be configured so that, as the secondwing 25 is slid onto the rod 30, the second wing 25 is movable over theprotuberances 60. Once the second wing 25 is slid onto the rod 30, thepin 50 may be slid into the opening 45, thereby spreading the rod 30. Inthis manner, the ratcheting members 120, 125, 130 should engage theprotuberances 60 and prevent movement when the second wing 25 is urgedin the opposite direction, for example, when removal of the second wing25 from the rod 30 is attempted. The second wing 25, thus, may beratcheted onto the rod 30. While the one-way ratcheting lock isdescribed with respect to the illustrated embodiment, it should beunderstood that other techniques may be used for the one-way ratchetinglock in accordance with embodiments of the present invention. Inaddition, while FIGS. 6-7 illustrate pin 50 used to spread the rod 30 sothat the ratcheting members 120, 125, 130 engage the protuberances 50,securing the second wing 25 on the rod 30, other suitable techniques maybe used to ratchet the second wing 25 onto the rod 30. By way ofexample, a cam may be used for expanding the rod 30 to engage theratcheting members 120, 125, 130 with the protuberances 60.Alternatively, the ratcheting members 120, 125, 130 may be hinged toallow movement over the protuberances 60 in one direction, but notmovement in the opposite direction.

Referring now to FIGS. 8-9, the spinous process fusion device 10 furthercomprising a central barrel 135 is illustrated in accordance withanother embodiment of the present invention. As illustrated, spinousprocess fusion device 10 comprises the body 15, the first wing 20, andthe second wing 25. In the illustrated embodiment, the body 15 furthermay comprise central barrel 135. Central barrel 135 may comprise firstside 140 and second side 145, which each extend on either side of therod 30. The first side 140 and the second side 145 may have widthsrespectively of about 10 millimeters to about 30 millimeters. Each ofthe first side 140 and the second side 145 may include a tapered end150. The tapered end 150 should facilitate insertion of the spinousprocess fusion device 10 into the interspinous space between adjacentvertebrae. Moreover, the width of the first side 140 and the second side145 generally should provide for distraction of the interspinous spaceduring placement of the device 10. Thus, the device 10 may function, forexample, as both a spacer and a clamp. Moreover, the first side 140 andthe second side 145 generally should restrict and/or prevent rotation ofthe first wing 20 and the second wing 25 about the connecting portion 35and the rod 30, respectively. As illustrated in FIG. 4, the centralportion 70 of the first wing 20 may have a narrower width than the upperportion 65 and lower portion 75 thereof so that the upper portion 65 andthe lower portion 75 may extend over the first side 140 and the secondside 145 of the central barrel 135. Likewise, the central portion 95 ofthe second wing 25 may also have a narrower width than the upper portion90 and the lower portion 100 thereof. As such, the central barrel 135may act as a guide for the second wing 25 when it is inserted onto therod 30 so that it is in alignment with the first wing 20. The centralbarrel 135 further may comprise an end 155 that connects the first side140 and the second side 145. The end 155 may comprise an opening 160through which the pin (not illustrated) may be inserted, in certainembodiments.

As previously mentioned, the spinous process fusion device 10 may beimplanted in a patient to, for example, immobilize the spinous processesof adjacent vertebrae. An embodiment of implanting the spinous processfusion device 10 in a patient may comprise inserting a spinous fusiondevice 10 comprising a body 15 and a first wing 20 between adjacentspinous processes of a patient. The spinous fusion device 10 generallymay be inserted until the teeth 80 of the first wing 20 engage theadjacent spinous processes both above and below the interspinous space.In certain embodiments, the second wing 25 generally may not be on thedevice 10 when it is inserted. If used, the central barrel 135 mayprovide for distraction of the interspinous space during placement ofthe device 10. However, it should be understood that additionaltechniques and/or devices may be used for distraction of theinterspinous space. In addition, the design of the spinous processfusion device 10 generally should allow its insertion between adjacentspinous processes without removal of the supraspinous ligament. Once thespinous fusion process device 10 has been placed between the adjacentspinous processes, the second wing 25 may be placed onto the rod 30 suchthat the teeth 105 of the second wing 25 engage the adjacent spinousprocesses both above and below the interspinous space. The second wing25 generally may be positioned on the rod 30 such that the first wing 20and the second wing 25 clamp the spinous processes in place. Once thesecond wing 25 is positioned in the desired location, the pin 50 may beplaced into opening 45 of the rod 30 to expand the rod 30, engaging theratcheting members 120, 125, 130 with the protuberances 60. The one-wayratcheting lock from interaction of the protuberances 60 of the rod 30and the ratcheting members 120, 125, 130 of the second wing 25 generallyshould prevent removal of the second wing 25. In this manner, the lumbarmotion segment may be immobilized, for example, without the need foradditional devices.

FIGS. 10-11 illustrate an embodiment of the spinous process fusiondevice 10 having a rotating wing. As illustrated, the first wing 20 maybe rotatably connected to the body 15, in accordance with embodiments ofthe present invention. Rotating of the first wing 20 about its centralaxis may allow the device 10, for example, to better conform to thepatient's anatomy. In the illustrated embodiment, the first wing 20 isrotatably connected to the body 15 at pin 155. The central portion 70 ofthe first wing 20 may be generally curved for fitting around a portionof the pin 155. The pin 155 may fit through a corresponding opening 160in a rounded end 165 of rod 30. Pin 155 may be tightened, for example,to lock the first wing 20 in a desired position. In operation, thesecond wing 25 may be placed onto the device 10 so that the first wing20 and the second wing 25 may clamp adjacent spinous processes in place.As previously discussed, the device 10 may include a one-way ratchetinglock, in which the interaction of the protuberances 60 with the secondwing 25 should prevent removal of the second wing 25. While notillustrated, the central barrel 135 may be used, for example, to providefor interspinous distraction.

FIGS. 12-14 illustrate an embodiment of the spinous process fusiondevice 10 having an expandable wing. As illustrated, the first wing 20may be expandable, in accordance with embodiments of the presentinvention. By way of example, each of the upper portion 65 and the lowerportion 75 of the first wing 20 may be pivotably connected to the body15 at pin 155. The upper portion 65 and lower portion 75 may each have agenerally rounded end 170 for fitting around the pin 155. The pin 155may fit through a corresponding opening 160 in a rounded end 165 of rod30. The upper portion 65 and the lower portion 75 may each pivot at thepin 155 from a folded position (FIG. 13) to an upright position (FIG.14). Pin 155 may be tightened, for example, to lock the first wing 20 ina desired position. While not illustrated, teeth generally may bepresent on the first wing 20 and/or the second wing 25 for engaging thespinous processes. In operation, the first wing 20 generally may expand,for example, as the device 10 is inserted into the interspinous spacebetween adjacent spinous processes. Once the device 10 is positioned asdesired, the second wing 25 may be placed onto the device 10 so that thefirst wing 20 and the second wing 25 may clamp adjacent spinousprocesses in place. As previously discussed, the device 10 may include aone-way ratcheting lock, in which the interaction of the protuberances60 with the second wing 25 should prevent removal of the second wing 25.Alternatively, a set screw (not shown) may be used to lock the secondwing 25 on the device 10. While not illustrated, the central barrel 135may be used, for example, to provide for interspinous distraction.

FIGS. 15-17 illustrate another embodiment of the spinous process fusiondevice 10 having an expandable wing. As illustrated, the first wing 20may further include an expandable flange 170 on the side facing thesecond wing 25, in accordance with embodiments of the present invention.The expandable flange 170 generally may provide for distraction of theinterspinous space. In the illustrated embodiment, the first wing 20 isexpandable. For example, the upper portion 65 and the lower portion 75of the first wing 20 may each be pivotably connected at pin 155. Theupper portion 65 and the lower portion 75 each may pivot at the pin 155from a folded position (FIG. 16) to an upright position (FIG. 17). Inthe upright position, the expandable flange 170 generally should extendfrom the first wing 20 along the body 15. Pin 155 may be tightened, forexample, to lock the first wing 20 and thereby the expandable flange 170in a desired position. While not illustrated, teeth generally may bepresent on the first wing 20 for engaging the spinous processes. Inoperation, the first wing 20 generally may expand, for example, as thedevice 10 is inserted into the interspinous space between adjacentspinous processes. When the first wing 20 expands, the expandable flange170 should extend from the first wing 20 thereby providing interspinousdistraction. Once the device 10 is positioned as desired, the secondwing 25 may be placed onto the device 10 so that the first wing 20 andthe second wing 25 may clamp adjacent spinous processes in place. A setscrew (not shown) may be inserted into opening 175 in the second wing 25to lock the second wing 25 on the device 10. In an alternativeembodiment, the device 10 may include a one-way ratcheting lock, inwhich the interaction of protuberances (not illustrated) with the secondwing 25 should prevent removal of the second wing 25.

FIGS. 18-20 illustrate another embodiment of the spinous process fusiondevice 10 having an expandable wing. The embodiment of the spinousprocess fusion device 10 illustrated in FIGS. 18-20 is similar to thedevice of FIGS. 12-14, except that the illustrated spinous processfusion device 10 has a thicker body 15. The thicker body 15 shouldgenerally provide for distraction of the interspinous space duringplacement of the device 10. Thus, the device 10 may function as both aspacer and a clamp. As illustrated, the body 15 includes an upperportion 180 and a lower portion 185. Each of the upper portion 180 and alower portion 185 include a tapered end 190. The tapered end 190 shouldfacilitate insertion of the spinous process fusion device 10 into theinterspinous space between adjacent vertebrae. On the opposite side ofthe body 15 from the tapered end 190, a pivot end 195 is located thatconnects the upper portion 180 and the lower portion 185. The pivot end195 may include a pivot axis 200 that permits pivoting of the upperportion 180 and lower portion 185 from a folded position (FIG. 19) to anopen position (FIG. 20). The upper portion 180 and lower portion 185 ofthe body 15 further include a wing opening 205 through which the firstwing 20 and the second wing 25 extend. As illustrated, the first wing 20and/or the second wing 25 may expandable, in that at least one of thewings may expand from a folded position to an upright position. Asillustrated, the second wing 25 may expand from a folded position (FIG.19) to an upright position (FIG. 18). The body 15 may be configured tofacilitate folding of the wing(s). By way of example, the body 15 maycontain an angled portion 210 to facilitate folding of the second wing25. As illustrated, the angled portion 210 may be located on a portionof the upper portion 180 that is adjacent the wing opening 205. Whilenot illustrated, a corresponding angled portion and wing opening may belocated in the lower portion 185 of the body 15.

FIGS. 21-23 illustrate another embodiment of the spinous process fusiondevice 10. As illustrated, the first wing 20 and the second wing 25 maybe shaped (for example, with a cutout) to facilitate stacking of morethan one spinous process fusion device 10. The second wing 25, forexample, may be shaped so that that upper portion 65 and the lowerportion 75 will mate. In this manner, an upper portion 65 of the secondwing 25 of one spinous process fusion device 10 may contact the samespinous process of the lower portion 65 of the second wing 25 of anotherspinous process fusion device 10. Once the device 10 is positioned asdesired, the second wing 25 may be placed onto the device 10 so that thefirst wing 20 and the second wing 25 may clamp adjacent spinousprocesses in place. As previously discussed, the device 10 may include aone-way ratcheting lock, in which the interaction of the protuberances(not shown) with the second wing 25 should prevent removal of the secondwing 25. Alternatively, a set screw (not shown) may be used to lock thesecond wing 25 on the device 10. While not illustrated, the centralbarrel 135 may be used, for example, to provide for interspinousdistraction.

FIGS. 24-28 illustrate another embodiment of the spinous process fusiondevice 10. As illustrated, the spinous process fusion device 10 maycomprise body 15, first wing 20, and second wing 25. In the illustratedembodiment, the body 15 generally may include a central core 210 and apost 215. The post 215 may extend from one end of the central core 210.The first wing 20 may be secured to the post 215 by set screw 220.Alternatively, the first wing 20 may be secured to the post 215 by aone-way ratcheting lock. The central core 210 includes a tapered end 225and a slot 230. The tapered end 225 should facilitate insertion of thespinous process fusion device 10 into the interspinous space betweenadjacent vertebrae. Moreover, the width of the central code 210generally should provide for distraction of the interspinous spaceduring placement of the device 10. Thus, the device 10 may function asboth a spacer and a clamp. Once the device 10 is positioned as desired,the second wing 25 may be placed into the slot 230 of the central core210 so that the first wing 20 and the second wing 25 may clamp adjacentspinous processes in place. As illustrated, the second wing 25, forexample, may have the general shape of the bar bell with the centralportion 95 having a rod-like shape for insertion into the slot 230. Anyof a variety of techniques may be used to secure the second wing 25 inthe slot 230. By way of example, a set screw (not shown) or a one-wayratcheting lock may be used for securing the second wing 25. Asillustrated in FIG. 28, the first wing 20 and/or the second wing may beconfigured to angulate on the body 15. By way of example, the first wing20 and/or the second wing 25 may be configured to rotate about theirrespective longitudinal axes. A pin (not shown) may be used tofacilitate this rotation, in certain embodiments.

FIGS. 29-31 illustrate an embodiment of the spinous process fusiondevice 10 having clampable wings. As illustrated, the spinous processfusion device 10 includes body 15, first wing 20, and second wing 25. Inthe illustrated embodiment, the body 15 includes rod 30 onto which thefirst wing 20 and the second wing 25 may be placed. The first wing 20and/or the second wing 25, for example, may have the general design of abear claw. First wing 20 is illustrated in more detail in FIGS. 30-31.As illustrated, the first wing may include an upper flap 235 and a lowerflap 240. The upper flap 235 and the lower flap 240 may both compriseteeth 80 for engaging the spinous processes. The upper flap 235 and/orthe lower flap 240 may each pivot about rod opening 245. By way ofexample, the upper flap 235 may pivot from an open position (FIG. 30) toa closed position (FIG. 31). In the closed position, the upper flap 235and the lower flap 240 may be engaging, for example, opposite sides of aspinous process. Any of a variety of techniques may be used to lock thefirst wing 20 in the closed position. For example, a set screw (notshown) or a one-way ratcheting lock (not shown) may be used to lock thefirst wing 20 in the closed position. The second wing 25 may have asimilar construction to the first wing 20. In addition, set screws (notshown) may be inserted into a respective screw opening 250 in the firstwing 20 and the second wing 25 to lock the wings onto the rod 30. In analternative embodiment, the device 10 may include a one-way ratchetinglock, in which the interaction of protuberances (not illustrated) withthe first wing 20 and/or the second wing 25 should prevent removal ofthe respective wing.

FIG. 32 illustrates another embodiment of the spinous process fusiondevice 10. As illustrated, the spinous process fusion device 10 includesbody 15, first wing 20, and second wing 25. The body 15 may include rodportion 255 and screw portion 260. In the illustrated embodiment, thefirst wing 20 is attached to one end of the rod portion 255. The firstwing 20, for example, may be in the general shape of an arrowhead. Thearrowhead shape should facilitate insertion of the spinous processfusion device 10 between adjacent spinous processes. The first wing 20further may comprise teeth 80 for engaging the spinous processes. Thesecond wing 25 may be in the general shape of a plate. The second wing25 may comprise teeth 105 for engaging the spinous processes. Once thedevice 10 is positioned as desired, the second wing 25 may be placedonto the device 10 over the screw portion 260 of the body 15.Alternatively, the device 10 may be inserted with the second wing 25 inplace. A fastener, such as nut 265, may draw together the first wing 20and the second wing 25 so that the wings may clamp adjacent spinousprocesses in place. The nut 265 should also secure the second wing 25 onthe screw portion 260 of the body 15.

FIGS. 33-34 illustrate an embodiment of the spinous process fusiondevice 10 having a pivoting scissor-type clamp. As illustrated, thespinous process fusion device 10 includes first wing 20, second wing 25,and set screw 270. The set screw 270 generally may connect the firstwing 20 and the second wing 25. The second wing 25 may be in thegenerally shape of a plate with an opening for insertion of the setscrew 270. In the illustrated embodiment, the first wing 20 is in thegeneral shape of a clamp jaw having a top jaw portion 275 and a bottomjaw portion 280. Each of the top jaw portion 275 and the bottom jawportion 280 contain teeth 80 for engaging the spinous processes.Additionally, each of the top jaw portion 275 and the bottom jaw portion280 has a handle 285. The top jaw portion 275 and the bottom jaw portion280 are connected at the set screw 270 such that the set screw acts as apivot for both the top jaw portion 275 and the bottom jaw portion 280.By way of example, the top jaw portion 275 and the bottom jaw portion280 may pivot from an initial position (FIG. 33) to an engaged position(FIG. 34). As illustrated by FIG. 33, the top jaw portion 275 and thebottom jaw portion 280 are both bent so that in the initial position thefirst wing 20 has an angled end that facilitates insertion of the device10 between adjacent spinous processes. Once the device 10 has beeninserted between adjacent spinous processes, the handle 285 of each thetop jaw portion 275 and the bottom jaw portion 280 may be used to pivotthe first wing 20 to the engaged position such that the teeth 80 of thefirst wing 20 engage the adjacent spinous processes both above and belowthe interspinous space. In the engaged position, the teeth 105 of thesecond wing 25 should also engage the adjacent spinous processes bothabove and below the interspinous space. Once the first wing 20 has beenpivoted to the engaged position, the screw 270 may be used to lock thedevice 10 in position. By way of example, the device 10 generally can belocked in a position in which the first wing 20 and the second wing 25clamp the spinous processes in place.

FIGS. 35-36 illustrate another embodiment of the spinous process fusiondevice 10 having a pivoting plate. As illustrated, the spinous processfusion device 10 includes body 15, first wing 20, and second wing 25. Inthe illustrated embodiment, the second wing 25 includes two wings, shownon FIGS. 35-36 as upper wing 290 and lower wing 295. As illustrated, theupper wing 290 and the lower wing 295 both may include a tapered end.Each of the upper wing 290 and the lower wing 295 include teeth 80.While not illustrated, the first wing 20 may also include teeth. In theillustrated embodiment, the upper wing 290 and the lower wing 295 arepivotably connected to the body 15 at pivot connection 300. By way ofexample, the upper wing 290 and the lower wing 295 may pivot from aninitial position (FIG. 35) to an engaged position (FIG. 36). Asillustrated, the upper wing 290 and the lower wing 295 may form arounded end 305 when the device 10 is in the initial position. Therounded end 305 may, for example, facilitate insertion of the device 10between adjacent spinous processes. Once the device 10 has been insertedbetween adjacent spinous processes, the second wing 25 may be movedalong the body 15 resulting in pivoting of the upper wing 290 and thelower wing 295 to the engaged position. As illustrated, the body 15includes a spreader 310 that extends from the second wing 25. The secondwing 25 may drive spreader 310 between the tapered ends of the upperwing 290 and the lower wing 295 forcing the wings to pivot to theengaged position. In the engaged position, the teeth 80 on the upperwing 290 and the lower wing 295 may engage the adjacent spinousprocesses both above and below the interspinous space. In the engagedposition, the teeth (if present) on the second wing 25 may also engagethe adjacent spinous processes both above and below the interspinousspace. In this manner, the first wing 20 and the second wing 25 mayclamp adjacent spinous processes in place. As previously discussed, thedevice 10 may include a one-way ratcheting lock, in which theinteraction of protuberances with the second wing 25 should preventremoval of the second wing 25.

FIGS. 37-39 illustrate an embodiment of the spinous process fusiondevice 10 having parallel distraction plates. As illustrated, thespinous process fusion device 10 includes a top distraction element 315,a bottom distraction element 320, and a plate 325. In certainembodiment, the top distraction element 315 and the bottom distractionelement 320 may be bent. For example, the top distraction element 315and the bottom distraction element 320 may be generally l-shaped. Asillustrated, the top distraction element 315 includes a base arm 330 andan extended arm 335. As illustrated, the extended arm 335 may extendtransversely and outwardly from one end of the base arm 330, forexample, with the base arm 330 and the extended arm 335 generallyforming a 90° angle. The bottom distraction element 320 also includes abase arm 340 and an extended arm 345. As illustrated, the extended arm345 may extend outwardly and transversely from one end of the base arm340, for example, with the base arm 340 and the extended arm 345generally forming a 90° angle. While not illustrated, the extended arms335, 345 may contain teeth for engaging spinous processes. The teeth mayextend from the extended arms 335, 345 on the same side as the base arms330, 340. In addition, the base arms 330, 340 may each have a taperedend so that when the device 10 is in an initial position (FIG. 37) thetop distraction element 315 and the bottom distraction element 320 forma tapered end 350. The tapered end 350 may facilitate insertion of thedevice 10 between adjacent spinous processes. When the device 10 is inthe initial position (FIG. 37), it may be inserted between adjacentprocesses. Once the device 10 has been inserted between adjacent spinousprocesses, the handle portions 355, 360 of the extended arms 335, 345may be used to spread the top distraction element 315 and the bottomdistraction element 320, resulting in movement of the device 10 to theengaged position (FIG. 38) and distraction of the interspinous space.The plate 325 may then be placed over the tapered ends of the base arms330, 335 to clamp the adjacent spinous processes in place. The plate 325generally should have openings 365, 370 for receiving the base arms 330,335. Any of a variety of suitable techniques may then be used to lockthe device 10 in place. By way of example, set screws may be used tolock in the base arms 330, 335 in the openings 365, 370 of the plate325.

FIG. 40 illustrates another embodiment of the spinous process fusiondevice 10. As illustrated, the spinous process fusion device 10 includesbody 15, first wing 20, and second wing 25. The body 15 may include atapered end 55 and a slot 375 formed in the body. The tapered end 55may, for example, facilitate insertion of the device 10 between adjacentspinous processes. While not illustrated, the first wing 20 and thesecond wing 25 may include teeth for engaging spinous processes. Thefirst wing 20 may be attached at the opposite end of the body 15 fromthe tapered end 55. The second wing 25 may include an opening 110 thatmay allow placement of the second wing 25 onto the body 15. The secondwing 25 also may include a tab portion 380 that is disposed generally inthe middle portion of the second wing 25. The tab portion 380 mayinclude an opening 385 for receiving a set screw. To lock the secondwing 25 on the body 15, the set screw may be inserted through theopening 110 and the slot 375. Accordingly, the second wing 25 may belocked on the body 15 at any position along the slot 375. Screwing at anangle may generally result in angulation of second wing 25.

FIGS. 41-42 illustrate another embodiment of a spinous process fusiondevice 10 of the present invention. As illustrated, the spinous processfusion device 10 includes body 15, first wing 20, top plate 390, andbottom plate 395. The body 15 may be generally t-shaped and have a baseportion 400 and two extended portions 405, 410 that extend transversallyand outwardly from opposite sides of one end of the base portion 400.Each of the extended portions 405, 410 may include an opening forreceiving an elongated member. In certain embodiments, the opening maybe threaded. The first wing 20 maybe attached to the base portion 400 atthe opposite end of the base portion 400 from the extended portions 405,410. The first wing 20, for example, may be in the general shape of anarrowhead. The arrowhead shape of the first wing 20 should facilitateinsertion of the spinous process fusion device 10 between adjacentspinous processes. While not illustrated, the first wing 20 further maycomprise teeth for engaging the spinous processes. The top plate 390 andthe bottom plate 395 may be coupled to respective elongated members,such as screws 415, 420. In certain embodiments, the top plate 390 andthe bottom plate 395 may be configured to angulate on their respectivescrew. The top plate 390 and the bottom plate 395 may include teeth 425,430 for engaging spinous processes. In the illustrated embodiment, whenthe screws 415, 420 are turned the plates 390, 395 should travel towardsthe first plate 20. When the screws 415, 420 are turned in the oppositedirection, the plates 390, 395 should travel away from the first plate20. To clamp adjacent spinous processes in place, the screws 415, 420may be turned until a spinous process is engaged between first wing 20and top plate 390, and an adjacent spinous process is engaged betweenfirst wing 20 and bottom plate 395.

FIGS. 43-44 illustrate another embodiment of a spinous process fusiondevice 10 of the present invention comprising a bolt 435 having athreaded portion 440. As illustrated, the spinous process fusion device10 comprises body 15, first wing 20, and second wing 25. In theillustrated embodiment, the body includes central barrel 135 and bolt435. As previously discussed, the central barrel 135 generally may havea width sufficient for distraction of the interspinous space. The firstwing 20 may comprise teeth 80, and the second wing 25 may also compriseteeth 105. Rotation of the bolt 435 should result in the first wing 20and the second wing 25 being drawn together. By way of example, thesecond wing 25 should move along the threaded portion 440 when the bolt435 is rotated. Rotation of the bolt 435 in the opposite directionshould result in movement of the first wing 20 and the second wing 25 inthe opposite direction. In operation, the second wing 25 may be placedonto the device and the bolt 435 such that the first wing 20 and thesecond wing 25 are drawn together clamping adjacent spinous processes inplace.

It should be understood that a variety of different techniques may beused in accordance with embodiments of the present invention to secure awing (e.g., second wing 25) onto the body 15. By way of example, FIGS.1-2 illustrate an embodiment in which a one-way ratcheting lock preventsremoval of second wing 25 from the body 15. Other suitable techniquesfor locking the second wing 25 may include use of a spreader-type lock,a camlock, a set screw, a threaded rod, or any of a variety of othertechniques some of which are described above.

FIGS. 45-47 illustrate an embodiment of the present invention thatincludes a camlock for securing a wing (e.g., second wing 25). Asillustrated, the second wing 25 generally may be placed over rod 30. Therod 30 generally may be configured such that the second wing 25 may besecured on the rod 30 by a camlock mechanism. With the camlockmechanism, axial rotation of the rod 30 should result in securing of thesecond wing 25 onto the body 15. FIG. 46 illustrates the camlock in aninitial position. FIG. 47 illustrates the camlock in a locked position.Those of ordinary skill in the art will appreciate that a camlockassembly may also be incorporated into embodiments of the presentinvention that include a one-way ratcheting lock. By way of example, thecamlock may be used to facilitate engagement of ratcheting members onthe second wing 25 with protuberances of the rod 30.

FIGS. 48-51 illustrate an embodiment of the present invention thatincludes a spreader-type lock for securing a wing (e.g., second wing25). As illustrated, the spinous process fusion device 10 may include abody 15 and a second wing 25. For purposes of this illustration, thefirst wing 20 is not shown. However, the first wing 20 generally shouldbe present during operation of the device 10, in accordance withembodiments of the present invention. In the illustrated embodiment, thesecond wing 25 generally includes a rod 30 that may be generallyconfigured to spread to increase the diameter of the rod 30. In theillustrated embodiment, the rod 30 generally may include an opening 45extending there through in the direction of pits longitudinal axis. Therod 30 may be configured so that insertion of the pin 50 or a screwspreads the rod 30. In this manner, the diameter of the rod 30 may beincreased. The diameter of the rod 30 prior to insertion of the pin 50generally should allow for movement of the second wing 25 over the rod.However, once the pin 50 has been inserted, the rod 30 should spread,securing the second wing 25 onto the body 15. FIG. 50 illustrates thespreader-type lock in the initial position. FIG. 51 illustrates thespreader-type lock in the locked position. As previously described, thespreader-type lock may be incorporated into embodiments of the presentinvention that include a one-way ratcheting lock.

The spinous process fusion device 10 may comprise, for example, any of avariety of biocompatible materials, including metals, ceramic materials,and polymers. Examples of biocompatible materials include titanium,stainless steel, aluminum, cobalt-chromium, alloys, and polyethylene. Byway of example, one or more components (e.g., central barrel 25, centralcore 210, etc.) of the device 10 may comprise polyetheretherketone.

While it is apparent that the invention disclosed herein is wellcalculated to fulfill the objects stated above, it will be appreciatedthat numerous modifications and embodiments may be devised by thoseskilled in the art.

What is claimed is:
 1. A surgical method comprising: providing a spinousprocess fusion device, wherein the device comprises: a body; a firstwing, wherein the first wing includes upper and lower teeth; and asecond wing, wherein the second wing includes upper and lower teeth;inserting the body and the first wing into a patient without the secondwing, wherein the first wing is inserted such that the upper teeth ofthe first wing contact a first spinous process and the lower teeth ofthe first wing contact a second spinous process; and inserting thesecond wing into the patient, wherein the second wing is inserted suchthat the upper teeth of the second wing contact the first spinousprocess and the lower teeth of the second wing contact the secondspinous process, wherein the second wing extends around the body,wherein the body comprises a rod, and wherein the body further comprisesa central barrel having a first side and a second side, wherein thefirst side is positioned on a first side of the rod and the second sideis positioned on a second side of the rod.
 2. The surgical method ofclaim 1, wherein the device is inserted into the patient without removalof the supraspinous ligament.
 3. The surgical method of claim 1, whereinthe first side has a tapered end and the second side has a tapered end.4. The surgical method of claim 1, wherein a one-way ratchetingmechanism is formed between the second wing and the rod.
 5. The surgicalmethod of claim 1, wherein the rod has proturbances.
 6. The surgicalmethod claim 1, wherein the rod is spreadable.
 7. The surgical method ofclaim 6, wherein the rod is spreadable via a pin inserted into the rod.8. The surgical method of claim 1, wherein the first wing is capable ofrotation.
 9. A surgical method comprising: providing a spinous processfusion device, wherein the device comprises: a body; a first wing; and asecond wing; inserting the body and the first wing into a patientwithout the second wing, wherein the first wing is inserted such that anupper portion of the first wing contacts a first spinous process and alower portion of the first wing contacts a second spinous process; andinserting the second wing into the patient, wherein the second wing isinserted such that an upper portion of the second wing contacts thefirst spinous process and a lower portion of the second wing contactsthe second spinous process, wherein the second wing extends around thebody, wherein the body further comprises a barrel having a first sidethat extends along a first side of the rod and a second side thatextends along a second side of the rod.
 10. The surgical method of claim9, wherein the first wing comprises a plurality of teeth and the secondwing comprises a plurality of teeth.
 11. The surgical method of claim 9,wherein the first wing is fixed relative to the body and the second wingis movable relative to the body.
 12. The surgical method of claim 11,wherein the second wing is movable via a one-way ratcheting mechanism.13. The surgical method of claim 9, wherein the body comprises a rod.14. The surgical method of claim 13, wherein the rod has proturbancesformed thereon.
 15. The surgical method of claim 13, wherein the rod isspreadable.
 16. The surgical method of claim 9, wherein the first wingis rotatable relative to the body.
 17. The surgical method of claim 9,wherein the first wing is expandable.